In this era of precision oncology and targeted therapies for cancer, it’s even more important to include different populations when doing clinical trials. Here are three effective strategies.
Lack of racial and ethnic diversity in cancer clinical trials leads to unanticipated treatment-related side effects among the broader cancer patient population after FDA approval, says Ana Maria Lopez, MD, a medical oncologist at Thomas Jefferson University in Philadelphia and chair of the health equity initiative at the American Society of Clinical Oncology.
Aditi Shastri, MD, an oncologist who specializes in the treatment of blood-related cancers at Montefiore Medical Center in Bronx, New York, agrees that the lack of racial diversity in clinical trials is a challenge. “In this era of precision oncology and targeted therapies and needing to treat specific targets with immunotherapy, it’s even more important that we identify and include different populations when doing clinical trials.”
Shastri points out, for example, that African American women have a much higher rate of triple negative breast cancer than white women.
In fact, more than 80% of cancer clinical trial participants are white and 59% are male, according to a 2013 study published in Cancer. A 2016 study published in North Carolina Medical Journal isolated a “significant and widening” racial disparity among male clinical trial participants.
Both Shastri and Lopez, who have run cancer clinical trials, say the following strategies can increase racial and ethnic diversity:
1. Establishing more trust. Lopez says clinical trial developers should ask community leaders, “What do you need? What things are important to you?”
While the cancer center’s immediate goal is to increase diversity within clinical trials, the community may be more interested in removing dangerous levels of lead within its water supply. Thus, she recommends offering the appropriate resources to help remedy the water situation in an effort to establish trust and build community.
2. Educating the community. Receiving a cancer diagnosis is a chaotic time for a patient, which is why Lopez recommends reaching out to the community before patients receive a cancer diagnosis. Proactive education about clinical trials gives people time to digest the information, she adds.
Proactive outreach is important because there are members of the African American community, for example, who don’t trust clinical trials in part because of the U.S. government’s “Tuskegee Experiment,” says Shastri. (In that study, hundreds of African American men were included in a 40-year study about syphilis where study participants didn’t provide informed consent, nor did they necessarily receive treatment for the disease, according to the CDC.)
3. Including friends and family in decision-making. Many of the patients treated at Montefiore Medical Center are Spanish speakers, so it’s helpful to be mindful of language and cultural differences, says Shastri. To address the first concern, she recommends hiring more people who speak the languages of the patients served.
In addition, many of her patients involve their extended family and even church friends in their medical decision-making. To address this, she first shares information with patients on a one-on-one basis; then she’ll facilitate a larger meeting that includes other family members and close friends.
Shastri cautions that these discussions can sometimes “get out of hand” because there are so many people in the room. Her advice? Always bring the conversation back to what’s best for the patient.